MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPS-ITE CRKSCRW 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that a bio-composite corkscrew, ar-1927bcf-3, was used during a procedure.As the surgeon was sewing the soft tissue around the tibia, he inserted the corkscrew and completed the case with no issue.After the procedure, the surgeon realized that the driver tip was broken off.The surgeon took an x-ray and he found that the broken piece was still in the patient.The surgeon thought it would cause more harm to do a second surgery, so therefore a second surgery is not planned.Additional information provided 11/20/19: sewing of soft tissue around the tibia was the main purpose of the surgery.The tip of the driver was lodged in the head of the anchor.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that the distal end of the returned ar-1927bcf-3 driver had broken off of the shaft of the device, leaving approximately 109.06mm of the shaft remaining.The fragmented tip was not returned for investigation.Material analysis concluded that the ar-1927bcf-3 driver met all as-received specifications.As such, the observed condition is most likely the result of prying/leveraging the device during use.It was noted that the bone quality encountered during the procedure was not recorded.

• Brand Name: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9396563
• Report Number: 1220246-2019-01447
• Device Sequence Number: 2708088
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: 00888867023369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: BIO-COMPS-ITE CRKSCRW 5.5X14.7MM
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 10302624
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other